Quality Engineer II Location : Gyeonggi-do, Korea, Republic of Job Family : Quality Job Type : Regular Posted : Sep 8, 2025 Job ID : 59335 Back to Search Results Job Description Apply Now > Save JobJob Saved This role oversees non-conformities, CAPAs, change controls, complaint management, and the review and approval of equipment qualification and validation activities to ensure the integrity and effectiveness of the QMS. Also train and mentor staff on quality policies, procedures, and regulatory expectations, and collaborate with marketing and sales teams to support client audits and requirements. + Provide expert guidance on GMP compliance and quality assurance best practices. + Lead internal audits, including planning, conducting, reporting, and following up on audit findings. + Oversee management of non-conformities, corrective and preventive actions (CAPA), change controls, and complaint handling. + Review and approve equipment qualification (IQ, OQ, PQ) and validation activities to ensure compliance with regulatory and company standards. + Ensure the QMS is effectively maintained, updated, and communicated across all relevant departments. + Develop and deliver training programs to staff on quality policies, procedures, and regulatory requirements. + Collaborate closely with marketing and sales teams to prepare for and support client audits and meet customer requirements. + Maintain comprehensive and accurate documentation related to quality activities, equipment qualification, and validation. + Participate in continuous improvement initiatives to enhance quality and compliance. Qualifications + Provide expert guidance on GMP compliance + Lead internal including preparation, execution, and follow-up on findings + Oversee non-conformities, CAPAs, change controls, and complaint management processes. + Ensure the QMS is effectively maintained, updated, and communicated across departments. + Train and mentor staff on quality policies, procedures, and regulatory expectations. + Collaborate with marketing and sales team to support client audit and requirement + Preferred certificate as a quality auditor (e.g. ISO9001) + Experience with EQMS + Bachelor’s degree in Chemistry, Biotechnology, or related field + Minimum 10 years of experience QA roles within GMP-regulated pharmaceutical or biopharmaceutical industries.